BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 3190504 · Received June 21, 2013

    Report

    Report Number
    9616662-2013-00015
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    MERIT MEDICAL IRELAND, LTD.
    Product Code
    DQO
    PMA / PMN Number
    K913161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. THE USER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. PROCESS EVAL. CONCLUSIONS: DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE VALVE WITHIN THE MANIFOLD IS TOO TIGHT OR RIGID. THE PHYSICIAN HAD TO APPLY GREAT FORCE TO DRAW CONTRAST INTO THE SYSTEM. BUBBLES WERE THEN SEEN BY THE USER IN THE SYSTEM. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282546 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL IRELAND, LTD. K458599

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTRAST MEDIA